Method of Manufacturing a Medical Device

Abstract

The invention relates to a method of manufacturing a medical device (1, 299, 399), the method comprising: (i) receiving in a first cleanroom environment categorised by a first airborne particulate cleanliness a plurality of medical components (10, 20, 50, 50′, 210, 220, 320, 350) prepared in a second cleanroom environment categorised by a second airborne particulate cleanliness, which is higher than the first airborne particulate cleanliness, where each of the plurality of medical components (10, 20, 50, 50′, 210, 220, 320, 350) comprises a sealed surface portion, (ii) assembling at least the plurality of medical components (10, 20, 50, 50′, 210, 220, 320, 350) in the first cleanroom environment, thereby providing a sub-assembly, and (iii) establishing an enclosure for the sub-assembly capable of maintaining an internal airborne particulate cleanliness equivalent to the first airborne particulate cleanliness.

Description

FIELD OF THE INVENTION[0001]The present invention relates to the manufacturing of medical devices, particularly to the manufacturing of medical devices comprising one or more aseptic surface portions.BACKGROUND OF THE INVENTION[0002]When performing a medically related activity that involves the introduction of a foreign object into the body of a subject, it is paramount to use sterile equipment in order to avoid infection. For example, when administering a parenteral drug intravenously both the drug product and the infusion set through which it is delivered should be sterile to eliminate the risk of bloodstream contamination.[0003]Some pharmaceutical drugs adapted for parenteral administration are only stable in the administrable form a relatively short period of time. For convenience reasons, and in order to extend the shelf life of such a drug, it is sometimes preferred to store individual constituents of the drug separately and to mix them only just before a dose is needed.[0004]...

AI Technical Summary

Benefits of technology

The invention was developed to solve the problems of prior art methods, specifically in terms of cost-efficient use of cleanroom resources and providing a safer device that reduces the risk of contamination. The technical effects of this patent include providing a cost-effective and safe method for manufacturing medical devices.

Problems solved by technology

Some pharmaceutical drugs adapted for parenteral administration are only stable in the administrable form a relatively short period of time.

Because the mixing procedure involves a manual handling of the individual components in an environmentally often uncontrolled setting, and the injectable medium is transferred between vials by a syringe with a needle in a procedure that typically includes penetration of two rubber septa in order to establish fluid connection to the respective vial interiors, sterility may be compromised.

This is, however, often considered a hassle by the user (especially if she / he needs to mix the substances and administer the resulting drug quickly to avert a serious situation), and the precautionary measures are therefore prone to neglection.

While this system may offer a solution which diminishes the potential of contamination because it is sealed during the entire reconstitution process, the system is rather costly to produce due to the need for assembly and packaging of the constituent parts in a so-called ‘critical area’, a controlled environment characterised by an extremely high level of air cleanliness.

While this method acknowledges the attractiveness of using cleanrooms of different particulate-per-volume ratings during the manufacturing of a drug cartridge assembly it fails to provide a cost reducing solution for the post-sterilisation part of a medical device production.

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